Inserter for soft tissue or bone-to-bone fixation device and methods

ABSTRACT

A positioning and installation tool for a fixation implant is inserted through a single, simple drill hole and positioned in place. The device controls the degree to which the implant is deployed and prevents accidental disengagement of the device from the implant before deployment has completed. The device also guides the components of the implant involved in active tendon compression at the aperture of the bone tunnel. The implant is deployed simply by rotating a knob, thereby creating an anchor point of high stiffness and fixation strength. When deployment has completed, the inserter is disengaged from the affixed implant by simply pulling a release mechanism.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. 119(e) of the filingdate of Provisional U.S. Application Ser. No. 61/051,671, entitledInserter for Soft Tissue or Bone-to-Bone Fixation Device, filed on May8, 2009, which application is expressly incorporated herein byreference, in its entirety.

BACKGROUND OF THE INVENTION

The present invention relates generally to devices, systems and methodsfor material fixation, and, more particularly, to insertion devices forfixation implants utilized to attach soft tissue to bone, for thepurpose of the repair of many soft tissue injuries, such as in thereconstruction of the Anterior Cruciate Ligament (ACL).

SUMMARY OF THE INVENTION

The disclosed invention is an inserter, intended to be used inconjunction with a soft tissue or bone-to-bone fixation device that willallow a surgeon to repair many soft tissue injuries, such as an AnteriorCruciate Ligament (ACL) injury. The bone-to-bone fixation device, onceloaded with a soft tissue graft, is deployed into a prepared bone tunnelusing the invention described herein. The fixation implant is packagedsterile and preloaded onto the inserter. In a preferred embodiment, thedisclosed inserter device may be utilized with a fixation implant of thetype disclosed in commonly assigned U.S. patent application Ser. No.11/923,526 (the '526 application), entitled Methods and Systems forMaterial Fixation, filed on Oct. 24, 2007, and herein expresslyincorporated by reference in its entirety.

Current ACL repairs may be difficult to perform, require more steps,additional procedure time, extra drilling, external jigs or fixtures ormultiple assistants. The device is an easy to use positioning andinstallation tool for a femoral implant of the type disclosed in the'526 application. The device is inserted through a single, simple drillhole and positioned into place. The device controls the degree to whichthe implant is deployed and prevents accidental disengagement from theimplant before deployment has completed. The device also guides thecomponents of the implant involved in active tendon compression at theaperture of the femoral tunnel. The implant is deployed simply byrotating a knob, thereby creating a femoral anchor point of highstiffness and fixation strength. When deployment has completed, theinserter is disengaged from the affixed implant by simply pulling arelease mechanism.

The use of the device is straightforward, eliminating potential forconfusion that may arise when using other femoral fixation technologies.No additional accessories or steps are required. The only required stepin preparation for fixation is to locate and drill a single tunnelwithin the femur. The device is designed to be used by a single operatorto minimize the time and cost required to perform the procedure.

More particularly, there is provided a device for positioning anddeploying a fixation implant, which comprises a handle, an insertionshaft extending distally from the handle, an implant retention mechanismdisposed on a distal end of the insertion shaft, an implant deploymentcontrol disposed on the handle, and an implant release control disposedon the handle. A suture cleat is also preferably disposed on the handle,on which suture may be wrapped. A safety mechanism is disposed on thedevice for preventing unintentional actuation of the deployment control.Preferably, the deployment control comprises a rotatable knob and thesafety mechanism comprises a safety pin which is removable to permitrotation of the rotatable deployment knob.

The inventive insertion device further comprises a mechanism forlimiting rotation of the deployment knob to only one direction, whereinbecause the deployment knob may only be rotated in one direction, thedeployment knob may be advanced distally, but not retracted proximally.The implant retention mechanism comprises a ball detent mechanism. Theball detent mechanism comprises a detent ball, a detent ball retainer,and a ball detent rod. An insertion shaft spring is disposed on the balldetent rod.

The fixation implant comprises an implant screw for deploying thefixation implant. The implant screw comprises a head having a hole forengaging the detent ball. The implant release control comprises a knobwhich is movable proximally to disengage the implant retention mechanismfrom a fixation implant engaged therewith. A hex tube is disposed at thedistal end of the insertion shaft. The implant retention mechanism isdisposed on the hex tube and the hex tube has a recess for receiving aportion of the fixation implant.

The implant screw further comprises internal left-hand threads disposedon an interior surface in the head, defining the hole, so that theimplant screw may be disengaged from the fixation implant. A shafthaving external threads extends distally from the implant screw head.

In another aspect of the invention, there is provided a fixation implantfor securing soft tissue to bone or bone to bone, wherein the fixationimplant comprises an implant screw for deploying the fixation implant.The implant screw comprises a head having a hole for engaging a detentball forming part of an implant retention mechanism on an insertiontool. The implant screw further comprises internal left-hand threadsdisposed on an interior surface in the head, defining said hole, so thatthe implant screw may be disengaged from the fixation implant, and ashaft having external threads, extending distally from the head.

In still another aspect of the invention, there is disclosed a methodfor inserting a deployable fixation implant into an opening in bone.This method comprises steps of retaining the fixation implant on adistal end of an insertion tool, positioning the insertion tool in adesired bone opening, disengaging a safety mechanism so that adeployment control on the insertion tool may be actuated to deploy thefixation implant, and actuating the deployment control to advance ofcomponent of the fixation implant distally, so that portions of thefixation implant are expanded radially to engage adjacent bone. Thedisengaging step comprises removing a safety pin from the insertion toolto thereby permit rotation of the deployment control, and the actuationstep comprises rotating a knob of the deployment control. The inventivemethod further comprises a step of releasing the fixation implant fromthe insertion tool.

The invention, together with additional features and advantages thereof,may best be understood by reference to the following description takenin conjunction with the accompanying illustrative drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an insertion device constructed in accordancewith the principles of the present invention;

FIG. 2 is an exploded view of the insertion device illustrated in FIG.1;

FIG. 3 is a plan view of the insertion device of FIGS. 1 and 2 as it isbeing utilized for deploying an implant into a bone tunnel;

FIG. 4A is a plan view of an implant screw which forms a part of theimplant being deployed, utilized on conjunction with the insertiondevice of FIGS. 1-3 for deploying an implant;

FIG. 4B is a perspective view of the implant screw shown in FIG. 4A; and

FIG. 4C is a cross-sectional view of the implant screw of FIG. 4B, takenalong line 4C-4C.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The device 10 of the present invention is an inserter, used forpositioning and deployment of a fixation implant like that described inthe '526 application. The user interface features of the inserter 10,depicted in FIG. 1, are a handle 12, a safety pin 14, an insertion shaft16, a deployment knob 18, a release knob 20, and suture cleats 22.

At the end of the insertion device 10, a sutured soft tissue graft (notshown) is loaded onto the implant (not shown), and the free suturestrands (not shown) are secured to the suture cleats 22 to allow forsuture management and easy insertion of the graft complex. The suturecleats 22 are designed to be easily and quickly wrapped with suture.After the suture has been attached to the cleats, the inserter is placedinside a femoral tunnel 24 in the femur 26 of a patient (FIG. 3). Whenit has reached the desired deployment location, the inserter and implantare deployed. Deployment is performed by removing the safety pin 14 androtating the deployment knob 18 in a clockwise fashion until thedeployment knob 18 comes into contact with the inserter handle 12, oruntil it can no longer be turned. An implant (not shown) is attached tothe tip of the insertion shaft 16 by means of a ball detent mechanism(FIG. 2), comprising a detent ball 28, a detent ball retainer 30, and aball detent rod 32, on which is disposed an insertion shaft spring 34.The ball detent mechanism engages with a hole 36 (FIG. 4A, 4B, 4C) in animplant screw 38. Deployment motion of the inserter 10 is ratcheted andis limited to the clockwise direction to prevent accidentalundeployment. By rotating the deployment knob 18, the diamond wedge ofthe implant expands the implant arms outward, which provide fixation byengaging against the wall of the femoral tunnel 24. To disengage theimplant from the inserter 10, the implant release knob 20 is pulled,releasing the detent mechanism. The insertion device can then be removedfrom the soft tissue graft implant site after any suture has beendetached from the suture cleats 22.

The device may come preloaded with the fixation implant attached to theinserter tip 40 (FIG. 3). FIGS. 4A-4C show the implant screw 38, held toa hex tube 42 of the inserter 10 by means of the aforementioned balldetent mechanism and hole 36 in the implant screw. The head 44 of theimplant screw 38 has internal left hand threads 46 (FIG. 4C) in order toremove the screw if a revision of the implant should be necessary. Toremove the screw, a left-hand threaded removal tool is screwed into thehex head 44 of the screw, securing the screw to the removal tool. Thetool is then rotated in a counterclockwise direction to unscrew anddisengage the screw from the implant.

Now referring more particularly to FIG. 2, a threaded ratchet shaft 48has a multitude of cuts running parallel to its length, designed toengage a pawl 50, limiting its rotation to the clockwise direction. Thepawl 50 is fitted over a pawl axle 52 which rests inside a mated cavityin a handle bottom 54. As the threaded ratchet shaft 48 rotatesclockwise, the pawl 50 is deflected downwards towards the handle bottom54. When the pawl 50 comes into contact with one of the cuts in thethreaded ratchet shaft 48, it is returned to the engaging antirotationposition by a torsion spring 56. If motion is attempted in thecounterclockwise direction, the flat face of the cutout in the threadedratchet shaft 48 engages the flat face of the pawl 50, preventingantirotation. A leaf spring may be substituted for the pawl 50 andtorsion spring 56 if it is positioned such that it engages the flat faceof the threaded ratchet shaft 48.

The deployment knob 18 may be attached to the threaded ratchet shaft 48by means of an alignment pin 58. As the deployment knob 18 rotates thethreaded ratchet shaft 48 in a clockwise direction, it is translatedlinearly forward by a stationary translation nut 60. The translation nut60 is fitted inside a cavity in the handle bottom 54 and the handle top62. The deployment tube 64, which engages with and turns the implantscrew, is affixed to the threaded ratchet shaft 48. The threaded ratchetshaft 48 and implant screw are threaded so that the turn to travel ratioare 1:1 between the two components. Therefore, as the threaded ratchetshaft 48 and deployment tube 64 rotate, the per-turn linear travel ofthe threaded ratchet shaft 48 is equal to the linear travel of theimplant screw within the implant body.

The inserter tip 40 interfaces with the compression pads on the femoralimplant to prevent implant rotation and assists in aligning and guidingthe compression pads as they separate. The insertion shaft 16 ispreferably a hollow cylindrical collar that is allowed to freely slideover the deployment tube 64. An anti-rotation washer 66 has a machinedgroove that aligns to a longitudinal rib in the handle top 62. Theanti-rotation washer has a positive spring bias created by the insertionshaft spring 34. The insertion shaft spring 34 is constrained by a ribwithin the handle top 62. As the assembly of the inserter tip 40,insertion shaft 16, and anti-rotation washer 66 moves distally duringthe course of implant deployment, the insertion shaft spring 34compresses, providing a reaction force that ensures the inserter tip 40remains engaged with the implant.

The deployment tube 64 contains a hollow cylindrical center portion thatallows the ball detent rod 32 to slide freely within. The ball detentrod 32 also fits within the detent ball retainer 30 that is fixed insidethe tip of the deployment tube 64. The purpose of the detent ballretainer 30 is to retain the detent ball 28 within the deployment tube64 and to constrain its motion inwards and outwards from the engaginghex face of the deployment tube 64. The inside engaging hex face of thedeployment tube 64 is drilled in such a manner that the detent ball 28is prevented from falling out of the assembly yet is still allowed toprotrude enough for significant engagement with the implant screw.

The detent ball 28 is sandwiched above the detent ball retainer 30 andbelow the engaging hex face of the deployment tube 64. As the balldetent rod 32 slides into the detent ball retainer 30, it pushes thedetent ball 28 from the engaging hex face of the deployment tube 64. Inthis state, the detent ball 28 protrudes a distance out of the engaginghex face of the deployment tube 64 and is prevented from retracting backinto the engaging hex face by the support of the ball detent rod 32underneath.

The ball detent rod 32 is connected to a spring shaft 68 which isequipped with an engagement spring 70 that translates a positiveengagement force to the ball detent rod 32. The engagement spring 70 isconfined within the deployment knob 18 and a deployment knob cover 72which it is compressed by when the spring shaft 68 is retracted.

It is to be understood that the figures of the bone and anchors seenabove are purely illustrative in nature, and are not intended to limitthe application of the inventive embodiments to any particularphysiological application or purpose. The invention is applicable tomany different types of procedures involving, in particular, theattachment of connective or soft tissue to bone. All of the terms usedherein are descriptive rather than limiting, and many changes,modifications, and substitutions may be made by one having ordinaryskill in the art without departing from the spirit and scope of theinvention, which is to be limited only in accordance with the followingclaims.

1.-19. (canceled)
 20. A method of deploying a fixation implant in atunnel formed in a bone, comprising: positioning a fixation implantretained on a distal end of an insertion tool in a tunnel formed in abone, the fixation implant, comprising: an implant body having a distalend, a proximal end, and a longitudinal axis; a first arm on the implantbody, the first arm located at the distal end of the implant body andbeing outwardly deployable relative to the longitudinal axis of theimplant body for engaging a wall in the tunnel for implanting theimplant body in the tunnel; and a first compression pad on the implantbody, the first compression pad located at the proximal end of theimplant body and being outwardly deployable relative to the longitudinalaxis of the implant body for moving soft tissue that is situated betweenthe first compression pad and the wall in the tunnel away from thelongitudinal axis of the implant body for compressing the soft tissueagainst bone in the tunnel; and rotating a knob of the insertion toolrelative to a handle portion of the insertion tool, wherein saidrotating causes a rotatable element that is linked to the knob throughthe insertion tool to rotate relative to the longitudinal axis of theimplant body, the rotatable element extending longitudinally through theimplant body to engage a wedge disposed in the distal end of the implantbody such that rotating the rotatable element: (a) moves the wedge in aproximal direction inside the implant body so that the wedge contactsthe first arm and forces the first arm to deploy outwardly relative tothe longitudinal axis of the implant body; and (b) moves a proximaldeployment element that is located proximally of the wedge inside theimplant body in a distal direction so that the proximal deploymentelement contacts the first compression pad and forces the firstcompression pad to deploy outwardly relative to the longitudinal axis ofthe implant body.
 21. The implanting system of claim 20 furthercomprising disengaging a safety pin from the handle portion prior tosaid rotating, wherein the safety pin, prior to said disengaging,prevents said rotating.
 22. The implanting system of claim 20, whereinthe insertion tool allows for rotation of the rotatable element in onlyone direction relative to the longitudinal axis of the implant body whenthe rotatable element is extending longitudinally through the implantbody.
 23. The implanting system of claim 20 further comprising couplinga soft tissue graft to the fixation implant.
 24. The implanting systemof claim 23 further comprising securing a suture attached to the softtissue graft to a suture cleat on the insertion tool.
 25. The implantingsystem of claim 20, wherein said rotating is performed until the knobcontacts the handle portion of the insertion tool.
 26. The implantingsystem of claim 20, wherein the fixation implant further comprises asecond arm on the implant body, the second arm being located at thedistal end of the implant body and being outwardly deployable relativeto the longitudinal axis of the implant body for engaging the wall inthe tunnel for implanting the implant body in the tunnel.
 27. Theimplanting system of claim 26, wherein the second arm is separated fromthe first arm on the implant body.
 28. The implanting system of claim20, wherein the fixation implant further comprises a second compressionpad on the implant body, the second compression pad being located at theproximal end of the implant body and being outwardly deployable relativeto the longitudinal axis of the implant body for moving soft tissue thatis situated between the first compression pad and the wall in the tunnelaway from the longitudinal axis of the implant body for compressing thesoft tissue against bone in the tunnel.
 29. The implanting system ofclaim 28, wherein the second compression pad is separated from the firstcompression pad on the implant body.
 30. The implanting system of claim20, wherein the implant body has a longitudinal passage extending fromthe proximal end to the distal end of the implant body, the wedge andthe proximal deployment element positioned in the longitudinal passage.31. The implanting system of claim 20, wherein the implant body is sizedfor deployment through a 5-8 mm cannula.
 32. A method of deploying afixation implant in a tunnel formed in a bone, comprising: positioning afixation implant retained on a distal end of an insertion tool in atunnel formed in a bone, the fixation implant, comprising: an implantbody having a distal end, a proximal end, and a longitudinal axis; afirst arm on the implant body, the first arm located at the distal endof the implant body and being outwardly deployable relative to thelongitudinal axis of the implant body for engaging a wall in the tunnelfor implanting the implant body in the tunnel; and a first compressionpad on the implant body, the first compression pad located at theproximal end of the implant body and being outwardly deployable relativeto the longitudinal axis of the implant body for moving soft tissue thatis situated between the first compression pad and the wall in the tunnelaway from the longitudinal axis of the implant body for compressing thesoft tissue against bone in the tunnel; actuating a deployment systemthat extends longitudinally through the implant body, wherein saidactuating: (a) moves a distal deployment element of the deploymentsystem in a proximal direction inside the implant body so that thedistal deployment element contacts the first arm and forces the firstarm to deploy outwardly relative to the longitudinal axis of the implantbody; and (b) moves a proximal deployment element of the deploymentsystem in a distal direction inside the implant body so that theproximal deployment element contacts the first compression pad andforces the first compression pad to deploy outwardly relative to thelongitudinal axis of the implant body; and disengaging a safety pin froma handle portion of the insertion tool prior to said actuating, whereinthe safety pin, prior to said disengaging, prevents said actuating. 33.The implanting system of claim 32, wherein the distal deployment elementcomprises a wedge.
 34. The implanting system of claim 32, wherein theimplant body is sized for deployment through a 5-8 mm cannula.
 35. Theimplanting system of claim 32, wherein the fixation implant furthercomprises a second arm on the implant body, the second arm being locatedat the distal end of the implant body and being outwardly deployablerelative to the longitudinal axis of the implant body for engaging thewall in the tunnel for implanting the implant body in the tunnel. 36.The implanting system of claim 35, wherein the second arm is separatedfrom the first arm on the implant body.
 37. The implanting system ofclaim 32, wherein the fixation implant further comprises a secondcompression pad on the implant body, the second compression pad beinglocated at the proximal end of the implant body and being outwardlydeployable relative to the longitudinal axis of the implant body formoving soft tissue that is situated between the first compression padand the wall in the tunnel away from the longitudinal axis of theimplant body for compressing the soft tissue against bone in the tunnel.38. The implanting system of claim 37, wherein the second compressionpad is separated from the first compression pad on the implant body. 39.The implanting system of claim 32, wherein the implant body has alongitudinal passage extending from the proximal end to the distal endof the implant body, the distal deployment element and the proximaldeployment element positioned in the longitudinal passage.